Associate Director, Regulatory Strategy

The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead the regulatory strategy and facilitate submission of data packages to the EMA. The role is expected to serve as an EU Regional Lead for our mid/late-stage CNS programs and may have the opportunity to be the Regulatory Program Lead for early programs in Alnylam pipeline. The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role will represent RA on multidisciplinary product development subteams and Global Regulatory Team. Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on EU regulatory requirements, and interpreting regulatory intelligence for the internal teams.

Summary of Key Responsibilities

• Serve as EU Regional Lead for assigned program, or as Regulatory Program Lead, leading the Global Regulatory Team, for one of the early programs in the Alnylam pipeline.
• Work with the Global Regulatory Lead and Regulatory Affairs management to lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead EU HA interactions. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs), Marketing Applications, Paediatric Plans, Orphan Designation and Expedited Pathway Applications (e.g. PRIME), and any amendments.
• Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects.
• Serve as member of the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.
• Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.
• Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.
• Maintain regulatory files in a format consistent with internal requirements.
• Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.
• Provide EU specific regulatory intelligence to internal stakeholders as appropriate.

Qualifications

• Bachelor's degree with 6 or more years of experience in a Regulatory Affairs role; minimum of 8 years’ experience working in the biotech or pharmaceutical industry. Higher degree would be a plus.
• Excellent written and verbal communication skills, including negotiation and influencing skills.
• Solid understanding of regulations and experience in interpretation of guidelines.
• Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.
• Experience with regulatory filings, including electronic submissions, e.g., CTAs, post-marketing variations, safety reporting, paediatric plans, PRIME etc.
• MAA filing and Type II variation experience is preferred.
• Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.
• Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.
• Clear alignment with Alnylam Core Values including:
• Commitment to People,
• Fiercely Innovative,
• Purposeful Urgency,
• Open Culture, and
• Passion for Excellence.